ABSTRACT
Background:
The subcutaneous
implantable cardioverter-defibrillator (S-ICD) has demonstrated
safety and
efficacy for the
treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate
ventricular tachycardia or provide prolonged
bradycardia pacing support.
Objective:
The rationale and design of a prospective, single-
arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD
will be presented.
Methods:
A technical description of the modular cardiac rhythm management (mCRM) system (EMPOWER leadless pacemaker and EMBLEM S-ICD) and the implantation
procedure is provided. MODULAR
ATP (
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing) is a multicenter, international trial enrolling up to 300
patients at
risk of
sudden cardiac death at up to 60 centers trial design. The
safety endpoint of
freedom from major
complications related to the mCRM system or implantation
procedure at 6 months and 2 years are significantly higher than 86% and 81%, respectively, and all-cause
survival is significantly >85% at 2 years.
Results:
Efficacy endpoints are that at 6 months mCRM
communication success is significantly higher than 88% and the percentage of subjects with low and stable thresholds is significantly higher than 80%. Substudies to evaluate rate-responsive features and performance of the pacing module are also described.
Conclusion:
The MODULAR
ATP global
clinical trial will prospectively test the
safety and
efficacy of the first intercommunicating leadless pacing system with the S-ICD. This trial
will allow for robust validation of
device-
device communication, pacing performance, rate responsiveness, and system
safety.
